Direct healthcare professional communication (DHPC)
Direct healthcare professional communication (DHPC) is circulated whenever new information about the safety of medicine emerges.
DHPCs serve the purpose of supporting safe and effective use of medicines and are circulated when new important safety information about a medicine has been obtained.
The information usually originates from the European Medicines Agency, EMA, but a need for communicating matters may also arise with the national authorities (the Danish Medicines Agency) or the marketing authorisation holder for the medicine (referred to here as the pharmaceutical company or MAH). The pharmaceutical company is hereafter required to prepare safety information for relevant healthcare professionals, a so-called DHPC letter (or simply DHPC) that is subsequently subjected to quality assurance and disseminated by the Danish Medicines Agency. The information aims to ensure safe and effective use of medicines and may, for example, be disseminated at the close of a regulatory procedure. This could be a periodic safety update report (PSUSA procedure) or a safety investigation (referral) on the assessment of the safety of a medicine. The DHPC letter may also be used in the event of critical supply difficulties or product defects.
The content of the information and the receiving target group are determined jointly by the Danish Medicines Agency and the pharmaceutical company (usually based on a proposal from the EMA). The letter must not contain advertising or other commercial content.
The Danish Medicines Agency sends out the information electronically directly to the concerned healthcare professionals via e-Boks, thus ensuring prompt delivery to the target group. The circulated safety information is available at the website of the Danish Medicines Agency.
It is also possible to subscribe to the safety information that is circulated to healthcare professionals via the newsletters from the Danish Medicines Agency.
In addition to the DHPC letter that is sent directly to the above healthcare professionals, the information is, upon assessment of relevance, also sent to pharmacies, affected hospital departments, private hospitals, medicinal products committees and medical societies. Finally, the information is accessible via a link at the top of the concerned medicine’s page at pro.medicin.dk for a period of six months after circulation of the DHPC letter.